CataractNCT06707740
Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
Who may be able to join
None listed.
Who cannot join
- Moderate and severe dry eye
- There is irregular corneal astigmatism.
- Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
- The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Ophthalmology and Optometry Hospital
Wenzhou, Wenzhou, Zhejiang 325027
About this study
(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.
Read the detailed description
To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.
- Conditions
- Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 AcrySof IQ(SN6AT) implantation after cataract surgery. | Not described | |
| Group 2TECNIS（ZCU） implantation after cataract surgery. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsular bend index
The average value of the capsular bag bending stage in different positions of IOL represents the speed of the whole capsular bag bending formation in the eye.
Measured: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
IOL rotation degree
The difference of degrees between the actually measured Toric IOL astigmatism axes at two adjacent follow-up time points.
Measured: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
Toric IOL total axial deviation
The degree difference between the actual axial position and the target axial position of Toric IOL is different.
Measured: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707740
- Sponsor's protocol ID
- SSOCT-toric
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses
- ClinicalTrials.gov ID
- NCT06707740
- Acronym / sponsor ID
- SSOCT-toric
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.
Detailed description
To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 AcrySof IQ(SN6AT) implantation after cataract surgery. | – | – |
| Group 2TECNIS（ZCU） implantation after cataract surgery. | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Moderate and severe dry eye
- There is irregular corneal astigmatism.
- Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
- The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Capsular bend index
Time frame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
The average value of the capsular bag bending stage in different positions of IOL represents the speed of the whole capsular bag bending formation in the eye.
IOL rotation degree
Time frame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
The difference of degrees between the actually measured Toric IOL astigmatism axes at two adjacent follow-up time points.
Toric IOL total axial deviation
Time frame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
The degree difference between the actual axial position and the target axial position of Toric IOL is different.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capsular bend index (time frame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.